FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HANN-VAC TM, DISPOSABLE,SUCTION CATHETER
K Number: K903480
·
Decision Oct 1, 1991
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
2
Review Days
425
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Basic Information
- Device Name
- HANN-VAC TM, DISPOSABLE,SUCTION CATHETER
- K Number
- K903480
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Un-I-Med, Inc.
- Date Received
- August 2, 1990
- Decision Date
- October 1, 1991
- Product Code
- BSY
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | FDA class 1 | Anesthesiology |
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Other Clearances by Un-I-Med, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945191 | ENDOSCOPIC ACCESSORY | May 3, 1995 | Substantially Equivalent |